subject: Concept of process validation for pharmaceutical industry [print this page] Concept of process validation for pharmaceutical industry
CONCEPT OF PROCESS VALIDATION FOR PHARMACEUTICAL INDUSTRY
CONCEPT OF VALIDATION
According to GMP definition Validation is "Establishing documented confirmation which provides a high degree of declaration that a specific process will consistently produce a product meeting its pre-determined qualifications and quality attributes."
Suitable and absolute certification is recognized as being critical to the validation effort. Standard Operating Procedures (SOPs), manufacturing formulae, detailed batch documentation, change control systems, investigational coverage systems, analytical documentation, development information, validation protocols and reports are integral components of the validation philosophy. The validation credentials provide a source of information for the ongoing process of the facility and are a resource that is used in succeeding process development or modification activities.
All validation behavior will incorporate a level of Impact appraisal to ensure that systems, services and products directly prejudiced by the testing have been recognized.
A revalidation program should be implemented based on routine apparatus revalidation requirements and on the modify Control Policy.
Types of Validation
Prospective validation
Establishing documented evidence that a piece of equipment/process or system will do what it purports to do, base upon a pre-planned series of technical tests as defined in the Validation Plan.
Concurrent validation
When an existing process can be shown to be in a state of control by applying tests on samples at tactical points throughout a process; and at the end of the process. All data is collected concurrently with the accomplishment of the process until sufficient information is available to make obvious process reproducibility.
Retrospective validation
Establishing documented confirmation that a process does what it purports to do, base on review and analysis of chronological data.
Design Qualification (DQ)
The objective of the DQ is met during the design and commissioning process by a number of mechanisms, which include:
1. Generation of User Requirement Specifications
2. Verification that design meets relevant user requirement qualifications
3. Supplier consideration /Audits
4. Challenge of the intend by GMP review audits
5. Product Quality Impact Assessment
6. Specifying Validation credentials requirements from equipment suppliers
7. Agreement with suppliers on the performance objectives
9. Defining construction and installation certification to assist with Installation Qualification (IQ).
Installation Qualification (IQ)
IQ provides documented evidence that the equipment or system has been developed, supplied and installed in accordance with design drawings, the supplier's recommendations and In-house requirements. Furthermore, IQ ensures that a record of the main features of the equipment or organization, as installed, is available and that it is supported by sufficient adequate documentation to enable satisfactory operation, preservation and change control to be implemented.
Operational Qualification (OQ)
OQ provides documented evidence that the equipment operates as intended throughout the specified design, operational or approved acceptance range of the equipment, as applicable. In cases where process steps are tested, an appropriate placebo batch will be used to make obvious equipment functionality. All new equipment should be fully commissioned prior to commencing OQ to ensure that as a minimum the apparatus is safe to operate, all mechanical assembly and pre-qualification checks have been completed, that the equipment is fully purposeful and that documentation is complete.
Performance Qualification (PQ)
The purpose of PQ is to provide recognized evidence that the equipment can consistently achieve and maintain its performance qualifications over a prolonged operating period at a defined operating point to produce a product of pre-determined quality. The performance specification will reference procedure parameters, in-process and product specifications. PQ requires three product batches to meet all recognition criteria for in-process and product testing. For utility systems, PQ requires the utility intermediate to meet all specifications over a prolonged sampling period.
The PQ documentation should reference standard manufacturing events and batch records and describe the method of sampling and testing to be used.
